Vertex has been at a standstill with U.K. authorities over its cystic fibrosis drug Orkambi, frustrating patients anxious to get the treatment. Now the House of Commons committee is getting involved, threatening to publicly release pricing documents if the sides can’t reach a deal.
In a letter (PDF) to Vertex CEO Jeffrey Leiden, MP Sarah Wollaston, chair of the Health and Social Care Committee, requested documents detailing the negotiations, including Vertex’s final offer made to NICE. Wollaston also requested evidence demonstrating that Vertex did, in fact, give England its best offer in the world, as the company previously stated.
The committee plans to publish the documents and will use its legal powers to “require the provision of those documents” if Vertex doesn’t comply, Wollaston wrote. The committee requested the documents by Nov. 30.
Wollaston is also reaching out to NHS England and NICE with similar requests, she wrote. The NHS has said it has made its largest financial commitment ever for Vertex CF drugs.
If the sides do reach a deal, the committee won't publish the documents or move forward with the inquiry, Wollaston wrote. According to Cystic Fibrosis Trust, the committee is a group of MPs who have the power to oversee the Department of Health and Social Care.
“The ability of the Committee to request this highly sensitive information, which hasn’t been public before, is powerful,” Cystic Fibrosis Trust Policy and Evidence Manager Anna Evans wrote in a post. “We hope that it acts to add greater urgency to discussions and avoid further dispute in the public domain.”
A Vertex representative said the company "welcomes the Committee's interest in access to cystic fibrosis medicines in England and we look forward to supporting its inquiry into this important issue."
Meanwhile, patient advocates are planning a protest next Monday calling for access to the drug that hasn’t been available in England despite a European approval back in 2015.
Vertex and health authorities have been trying for years to reach a deal for Orkambi. This summer, after negotiations failed to yield a deal, Vertex CEO Jeffrey Leiden took his complaints to the very top. He reached out to U.K. Prime Minister Theresa May to say that England’s decision to reject Vertex’s pricing offer devalued patient lives and threatened the U.K. biopharma ecosystem.
A week later, NHS England made a "final” offer that would have provided Vertex revenues of £500 million over 5 years and £1 billion over 10 years for its CF drugs, the agency's "largest ever financial commitment" in its 70-year history. Still, Vertex said the offer “fails to adequately reflect the value of our current and future medicines and the number of patients that will be treated with these medicines."
After those developments, Vertex in August said it wouldn’t ask England’s cost-effectiveness watchdog to review its new drug, Symkevi. Vertex director of external communications Heather Nichols said that’s because NICE’s “single technology appraisal has not kept pace with changes in medicine and has significant limitations in how it captures and values the full benefits of precision medicines.”
Vertex “would be happy to re-engage with NICE in the context of an appropriate appraisal process,” she added.
Editor's note: This story was updated with a statement from Vertex.